Market Newsdesk

SAN DIEGO
, Sept. 15, 2022 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today will present data on the effects of ONGENTYS^® (opicapone) capsules on soluble-catechol-O-methyltransferase (S-COMT) enzyme inhibition. These data (abstract #1025) are being shared at the MDS International Congress of Parkinson’s Disease and Movement Disorders^®September 15-18 in Madrid, Spain.

“These data demonstrate that COMT inhibition shown by opicapone leads to more consistent daily levodopa exposure, which continues to be a challenge and goal in treating Parkinson’s disease,” said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. “Adding a once-daily dose of opicapone 50 mg to levodopa/carbidopa resulted in inhibition of S-COMT activity and reduced fluctuations in L-dopa concentrations regardless of disease state, age, sex, ethnicity, or BMI.”

The post-hoc analyses were conducted using data from 2 previous open-label Phase 1 studies of ONGENTYS, an approved once-daily adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF time. Results of this post-hoc analysis showed that once-daily ONGENTYS 50 mg, when added to levodopa/carbidopa, decreased mean S-COMT activity by more than 80 percent in both patients with Parkinson’s disease and healthy participants. Mean percentage reduction in S-COMT activity was 79–85 percent for all subgroups in both individual and pooled studies, although some subgroups had small participant numbers. ONGENTYS also reduced inter-patient variability in S-COMT activity by 86 percent from baseline.

Neurocrine Biosciences will also present survey results (abstract #993) on the continuing educational needs of U.S. clinicians managing OFF episodes in Parkinson’s disease, demonstrating the variability in approach to managing OFF episodes and need for relevant Continuing Medical Education approaches.

A full list of abstracts being presented by Neurocrine Biosciences at MDS International Congress of Parkinson’s Disease and Movement Disorders^® is available on the meeting website.

About ONGENTYS^® (opicapone) Capsules 

ONGENTYS is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) in April 2020 as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “OFF” episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.

In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in several European countries. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.

Important Information (U.S.)

Approved Use

ONGENTYS^® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson’s disease (PD) who are having “OFF” episodes.

It is not known if ONGENTYS is safe and effective in children.

Important Safety Information

Do not take ONGENTYS if you:

• take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
• have a tumor that secretes hormones known as catecholamines.

Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you
:

• have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
• have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
• have a history of uncontrolled sudden movements (dyskinesia).
• have had hallucinations or psychosis.
• have liver or kidney problems.
• are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take
, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

What should I avoid while taking ONGENTYS?

Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

What are the possible side effects of ONGENTYS?

ONGENTYS may cause serious side effects, including:

• Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson’s disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
• Low blood pressure or dizziness, light headedness, or fainting.
• Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
• Seeing, hearing, or feeling things that are not real (hallucinations),
  believing things that are not real (delusions)
  , or aggressive behavior.
• Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see ONGENTYS full Product Information.

About Parkinson’s Disease
Parkinson’s disease is a chronic, progressive, and debilitating neurodegenerative disorder that affects approximately 1 million people in the U.S. and 6 million people worldwide. Parkinson’s disease is associated with low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking, and writing. As Parkinson’s disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement (bradykinesia), tremor, rigidity, impaired posture and balance, and difficulty with speech and writing.

There is presently no cure for Parkinson’s disease and management of the disease consists of the use of treatments that attempt to control motor symptoms primarily through dopaminergic mechanisms. The current gold standard for treatment of motor symptoms is levodopa/carbidopa. While levodopa/carbidopa improves patients’ motor symptoms, as the disease progresses, the beneficial effects of levodopa begin to wear off more quickly. Patients then experience motor fluctuations throughout the day between “on” time, periods when the medication is working and Parkinson’s disease symptoms are controlled, and “OFF” time, when the medication is not working and motor symptoms return.

About Neurocrine Biosciences

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as over a dozen mid- to late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, Twitter and Facebook. (*in collaboration with AbbVie).

Neurocrine, the Neurocrine logo, and ONGENTYS are registered trademarks of Neurocrine Biosciences, Inc.

Forward-Looking Statements

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from Neurocrine’s products and product candidates. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of ONGENTYS; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risks related to the development of our product candidates; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; risks associated with our dependence on BIAL for manufacturing activities for ONGENTYS, and our ability to manage BIAL; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended June 30, 2022. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

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SOURCE Neurocrine Biosciences, Inc.

JUNO BEACH, Fla.
, Sept. 15, 2022 /PRNewswire/ — NextEra Energy, Inc. (NYSE: NEE) announced today that it has agreed to sell $2.0 billion of equity units to Citigroup, Goldman Sachs & Co. LLC and Mizuho. The transaction is expected to close on Sept. 19, 2022.

Each equity unit will be issued in a stated amount of $50. Each equity unit will consist of a contract to purchase NextEra Energy common stock in the future and a 5% undivided beneficial ownership interest in a NextEra Energy Capital Holdings, Inc. debenture due Sept. 1, 2027, to be issued in the principal amount of $1,000. The debentures will be guaranteed by NextEra Energy Capital Holdings’ parent company, NextEra Energy, Inc. Total annual distributions on the equity units will be at the rate of 6.926%, consisting of interest on the debentures and payments under the stock purchase contracts.

Each stock purchase contract will require the holder to purchase NextEra Energy common stock for cash, based on a per-share price range of $88.88 to $111.10. The higher end of this price range reflects a premium of 25% over the New York Stock Exchange closing price of NextEra Energy common stock on Sept. 14, 2022, which was $88.88. The holders must complete the stock purchase by no later than Sept. 1, 2025, and their purchase obligations may be satisfied with proceeds raised from remarketing the debentures that comprise part of their equity units.

The net proceeds from the sale of the equity units, which are expected to be approximately $1.94 billion (after deducting the underwriting discount and other offering expenses), will be added to the general funds of NextEra Energy Capital Holdings. NextEra Energy Capital Holdings expects to use its general funds to fund investments in energy and power projects and for other general corporate purposes, including the repayment of its outstanding commercial paper obligations.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities to which this communication relates in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering may be made only by means of a prospectus and the related prospectus supplement, copies of which may be obtained from Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146).    

NextEra Energy, Inc.

NextEra Energy, Inc. (NYSE: NEE) is a leading clean energy company headquartered in Juno Beach, Florida. NextEra Energy owns Florida Power & Light Company, which is America’s largest electric utility that sells more power than any other utility, providing clean, affordable, reliable electricity to approximately 5.8 million customer accounts, or more than 12 million people across Florida. NextEra Energy also owns a competitive clean energy business, NextEra Energy Resources, LLC, which, together with its affiliated entities, is the world’s largest generator of renewable energy from the wind and sun and a world leader in battery storage. Through its subsidiaries, NextEra Energy generates clean, emissions-free electricity from seven commercial nuclear power units in Florida, New Hampshire and Wisconsin. NextEra Energy has been recognized often by third parties for its efforts in sustainability, corporate responsibility, ethics and compliance, and diversity. NextEra Energy is ranked No. 1 in the electric and gas utilities industry on Fortune’s 2022 list of “World’s Most Admired Companies,” recognized on Fortune’s 2021 list of companies that “Change the World” and received the S&P Global Platts 2020 Energy Transition Award for leadership in environmental, social and governance.

Cautionary Statements and Risk Factors That May Affect Future Results

This news release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but instead represent the current expectations of NextEra Energy, Inc. (together with its subsidiaries, NextEra Energy) regarding future operating results and other future events, many of which, by their nature, are inherently uncertain and outside of NextEra Energy’s control. In some cases, you can identify the forward-looking statements by words or phrases such as “will,” “may result,” “expect,” “anticipate,” “believe,” “intend,” “plan,” “seek,” “potential,” “projection,” “forecast,” “predict,” “goals,” “target,” “outlook,” “should,” “would” or similar words or expressions.  You should not place undue reliance on these forward-looking statements, which are not a guarantee of future performance.  The future results of NextEra Energy and its business and financial condition are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, or may require it to limit or eliminate certain operations. These risks and uncertainties include, but are not limited to, those discussed in this news release and the following: effects of extensive regulation of NextEra Energy’s business operations; inability of NextEra Energy to recover in a timely manner any significant amount of costs, a return on certain assets or a reasonable return on invested capital through base rates, cost recovery clauses, other regulatory mechanisms or otherwise; impact of political, regulatory, operational and economic factors on regulatory decisions important to NextEra Energy; disallowance of cost recovery based on a finding of imprudent use of derivative instruments; effect of any reductions or modifications to, or elimination of, governmental incentives or policies that support utility scale renewable energy projects or the imposition of additional tax laws, tariffs, duties, policies or assessments on renewable energy or equipment necessary to generate it or deliver it; impact of new or revised laws, regulations, interpretations or constitutional ballot and regulatory initiatives on NextEra Energy; capital expenditures, increased operating costs and various liabilities attributable to environmental laws, regulations and other standards applicable to NextEra Energy; effects on NextEra Energy of federal or state laws or regulations mandating new or additional limits on the production of greenhouse gas emissions; exposure of NextEra Energy to significant and increasing compliance costs and substantial monetary penalties and other sanctions as a result of extensive federal regulation of its operations and businesses; effect on NextEra Energy of changes in tax laws, guidance or policies as well as in judgments and estimates used to determine tax-related asset and liability amounts; impact on NextEra Energy of adverse results of litigation; effect on NextEra Energy of failure to proceed with projects under development or inability to complete the construction of (or capital improvements to) electric generation, transmission and distribution facilities, gas infrastructure facilities or other facilities on schedule or within budget; impact on development and operating activities of NextEra Energy resulting from risks related to project siting, planning, financing, construction, permitting, governmental approvals and the negotiation of project development agreements, as well as supply chain disruptions; risks involved in the operation and maintenance of electric generation, transmission and distribution facilities, gas infrastructure facilities, retail gas distribution system in Florida and other facilities; effect on NextEra Energy of a lack of growth or slower growth in the number of customers or in customer usage; impact on NextEra Energy of severe weather and other weather conditions; threats of terrorism and catastrophic events that could result from terrorism, cyberattacks or other attempts to disrupt NextEra Energy’s business or the businesses of third parties; inability to obtain adequate insurance coverage for protection of NextEra Energy against significant losses and risk that insurance coverage does not provide protection against all significant losses; a prolonged period of low gas and oil prices could impact NextEra Energy’s gas infrastructure business and cause NextEra Energy to delay or cancel certain gas infrastructure projects and could result in certain projects becoming impaired; risk of increased operating costs resulting from unfavorable supply costs necessary to provide full energy and capacity requirement services; inability or failure to manage properly or hedge effectively the commodity risk within its portfolio; effect of reductions in the liquidity of energy markets on NextEra Energy’s ability to manage operational risks; effectiveness of NextEra Energy’s risk management tools associated with its hedging and trading procedures to protect against significant losses, including the effect of unforeseen price variances from historical behavior; impact of unavailability or disruption of power transmission or commodity transportation facilities on sale and delivery of power or natural gas; exposure of NextEra Energy to credit and performance risk from customers, hedging counterparties and vendors; failure of counterparties to perform under derivative contracts or of requirement for NextEra Energy to post margin cash collateral under derivative contracts; failure or breach of NextEra Energy’s information technology systems; risks to NextEra Energy’s retail businesses from compromise of sensitive customer data; losses from volatility in the market values of derivative instruments and limited liquidity in over-the-counter markets; impact of negative publicity; inability to maintain, negotiate or renegotiate acceptable franchise agreements; occurrence of work strikes or stoppages and increasing personnel costs; NextEra Energy’s ability to successfully identify, complete and integrate acquisitions, including the effect of increased competition for acquisitions; environmental, health and financial risks associated with ownership and operation of nuclear generation facilities; liability of NextEra Energy for significant retrospective assessments and/or retrospective insurance premiums in the event of an incident at certain nuclear generation facilities; increased operating and capital expenditures and/or reduced revenues at nuclear generation facilities resulting from orders or new regulations of the Nuclear Regulatory Commission; inability to operate any of NextEra Energy’s owned nuclear generation units through the end of their respective operating licenses; effect of disruptions, uncertainty or volatility in the credit and capital markets or actions by third parties in connection with project-specific or other financing arrangements on NextEra Energy’s ability to fund its liquidity and capital needs and meet its growth objectives; inability to maintain current credit ratings; impairment of liquidity from inability of credit providers to fund their credit commitments or to maintain their current credit ratings; poor market performance and other economic factors that could affect NextEra Energy’s defined benefit pension plan’s funded status; poor market performance and other risks to the asset values of nuclear decommissioning funds; changes in market value and other risks to certain of NextEra Energy’s investments; effect of inability of NextEra Energy subsidiaries to pay upstream dividends or repay funds to NextEra Energy or of NextEra Energy’s performance under guarantees of subsidiary obligations on NextEra Energy’s ability to meet its financial obligations and to pay dividends on its common stock; the fact that the amount and timing of dividends payable on NextEra Energy’s common stock, as well as the dividend policy approved by NextEra Energy’s board of directors from time to time, and changes to that policy, are within the sole discretion of NextEra Energy’s board of directors and, if declared and paid, dividends may be in amounts that are less than might be expected by shareholders; NextEra Energy Partners, LP’s inability to access sources of capital on commercially reasonable terms could have an effect on its ability to consummate future acquisitions and on the value of NextEra Energy’s limited partner interest in NextEra Energy Operating Partners, LP; effects of disruptions, uncertainty or volatility in the credit and capital markets on the market price of NextEra Energy’s common stock; and the ultimate severity and duration of public health crises, epidemics and pandemics, and its effects on NextEra Energy’s business. NextEra Energy discusses these and other risks and uncertainties in its annual report on Form 10-K for the year ended December 31, 2021 and other Securities and Exchange Commission (SEC) filings, and this news release should be read in conjunction with such SEC filings. The forward-looking statements made in this news release are made only as of the date of this news release and NextEra Energy undertakes no obligation to update any forward-looking statements.

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SOURCE NextEra Energy, Inc.

NEW YORK
, Sept. 15, 2022 /PRNewswire/ — InvestorsObserver issues critical PriceWatch Alerts for NBRV, SONN, FSRD, VLCN, and VLD.

To see how InvestorsObserver’s proprietary scoring system rates these stocks, view the InvestorsObserver’s PriceWatch Alert by selecting the corresponding link.

• NBRV: https://www.investorsobserver.com/lp/pr-stocks-lp-2/?symbol=NBRV&prnumber=091520221 
• SONN: https://www.investorsobserver.com/lp/pr-stocks-lp-2/?symbol=SONN&prnumber=091520221 
• FSRD: https://www.investorsobserver.com/lp/pr-stocks-lp-2/?symbol=FSRD&prnumber=091520221 
• VLCN: https://www.investorsobserver.com/lp/pr-stocks-lp-2/?symbol=VLCN&prnumber=091520221 
• VLD: https://www.investorsobserver.com/lp/pr-stocks-lp-2/?symbol=VLD&prnumber=091520221 

(Note: You may have to copy this link into your browser then press the [ENTER] key.)

InvestorsObserver’s PriceWatch Alerts are based on our proprietary scoring methodology. Each stock is evaluated based on short-term technical, long-term technical and fundamental factors. Each of those scores is then combined into an overall score that determines a stock’s overall suitability for investment.

InvestorsObserver provides patented technology to some of the biggest names on Wall Street and creates world-class investing tools for the self-directed investor on Main Street. We have a wide range of tools to help investors make smarter decisions when investing in stocks or options.

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SOURCE InvestorsObserver

• Exclusive License Agreement to Develop and Commercialize Phase II Clinical Stage New Chemical Entity DA-1241 for the Treatment of NASH / Type 2 Diabetes and
• Phase I Ready DA-1726 for the Treatment of NASH / Obesity
• Dong-A Commits $15 Million in Equity to Strategic Collaboration

BOSTON and SEOUL, South Korea, Sept. 15, 2022 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (“NeuroBo”) (Nasdaq: NRBO), and Dong-A ST Co., Ltd. (“Dong-A”) (KOSE: A000640) today announced that they have entered into a conditional exclusive license agreement for NeuroBo to develop and commercialize DA-1241 and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis (NASH), obesity and type 2 diabetes.

DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, which promotes the release of key gut peptides GLP-1, GIP and PYY, which, in turn, play an important role in glucose metabolism, lipid metabolism and weight loss. DA-1241 is a synthetic, selective small molecule, suitable for oral administration and has been shown to be well tolerated in phase 1 studies. Further, its multimodal mechanism appears to induce strong anti-NASH effects, supported by potential best-in-class efficacy, as demonstrated in pre-clinical studies.

DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring, 37-amino acid peptide hormone that is released from the gut after ingestion of a meal, activating both the GLP-1 and glucagon receptors, prompting reduced food intake as well as an increase in energy expenditure, potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists. The beneficial effects of this dual mechanism of DA-1726 on weight loss compared to selective GLP-1 activity has been demonstrated in animal models. Additionally, DA-1726 has shown the ability to improve hepatic steatosis, inflammation and fibrosis when compared to the GLP-1 agonist, semaglutide in these same models.

Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies. Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea.  

“The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space — areas with enormous market opportunity,” stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. “Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH.”

“We are highly enthusiastic about this opportunity to accelerate development of our novel treatments in partnership with NeuroBo. Dong-A plans to continue to strengthen its R&D capability and to seek additional collaboration opportunities to establish ourselves in the US market”, said Min Young Kim, Chief Executive Officer of Dong-A.

Under the terms of the license agreement, Dong-A will receive an upfront payment of $22 million in Series A convertible preferred stock, which will automatically convert into common stock upon receipt of requisite stockholder approval, and will be eligible to receive commercial- and regulatory-based milestone payments, dependent upon the achievement of specific regulatory and commercial developments. Dong-A will also be entitled to single digit royalties on net sales of the two assets. Dong-A has also agreed to commit $15,000,000 toward financing the assets, subject to NeuroBo’s ability to obtain additional financing under the terms of the license agreement.

The license agreement has been approved by the board of directors of NeuroBo. The transaction is expected to close in the third quarter of 2022, subject to obtaining third party financing for development of the assets and other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by NeuroBo with the Securities and Exchange Commission (“SEC”) and will be available at www.sec.gov.

Honigman LLP is serving as legal counsel to NeuroBo. Moelis & Company is acting as financial advisor to Dong-A for the transaction and Willkie Farr & Gallagher LLP is serving as legal counsel to Dong-A.

NeuroBo Pharmaceuticals, Inc., is a clinical-stage biotechnology company historically focused on therapies for neurodegenerative, infectious, and, upon closing of the license agreement, cardiometabolic diseases. Its therapeutics programs currently include ANA001, an oral niclosamide formulation, which is in Phase 2/3 clinical trials to treat patients with moderate coronavirus disease (COVID-19); NB-01 for the treatment of painful diabetic neuropathy; NB-02 for the treatment of symptoms of cognitive impairment and to modify the progression of neurodegenerative diseases associated with the malfunction of tau protein; and gemcabene currently being assessed as an acute treatment for COVID-19 in combination with ANA001. NeuroBo Pharmaceuticals, Inc. is headquartered in Boston, Massachusetts. For more information, please visit www.neurobopharma.com.

Dong-A ST Co., Ltd. (KOSE: A000640) is a leading healthcare company in South Korea with a business focus on developing, manufacturing and distributing pharmaceutical products and medical devices worldwide. Dong-A has successfully developed and marketed several products globally and continues to develop prospective clinical candidates. Dong-A also provides licensed-in and licensed-out drugs, and medical devices, including high-technology medical devices, custom-made products, and sets of artificial cardiac circuits for use in open-heart surgery. Dong-A has over 5,500 employees including 2,300 in the pharmaceutical sector. Dong-A was founded in 1932 and is headquartered in Seoul, South Korea.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the licensing agreement, NeuroBo’s integration of the assets licensed therein, the effect of the proposed licensing transaction on NeuroBo’s business strategy, the market size and potential growth opportunities of NeuroBo’s current and future product candidates, NeuroBo’s capital requirements and use of proceeds, clinical development activities, the timeline for, and results of, clinical trials, regulatory submissions, and potential regulatory approval and commercialization of its current and future product candidates. Forward-looking statements are usually identified by the use of words, such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “may,” “potential,” “will,” “could” and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These factors, risks and uncertainties include, but are not limited to: (1) the structure, timing and ability to satisfy the conditions to closing the license agreement; (2) NeuroBo’s ability to be continued to be listed on the NASDAQ Capital Market; (3) the ability to realize the benefits of the license agreement, including the impact on future financial and operating results of NeuroBo; (4) the ability to integrate the new product candidates to be licensed as part of the transaction into NeuroBo’s business in a timely and cost‐efficient manner; (5) the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; (6) costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; (7) changes in applicable laws or regulations; (8) effects of changes to NeuroBo’s stock price on the terms of the license agreement and any future fundraising; and (9) the ability of NeuroBo to successfully raise funds to meet the conditions of the license agreement. Please refer to NeuroBo’s most recent annual report on Form 10-K, as well as NeuroBo’s subsequent filings on Form 10-Q and Form 8-K, which are available on the SEC’s website (www.sec.gov), for a full discussion of the risks and other factors that may impact any forward-looking statements in this press release. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof.

Contacts

Investors & Media:

NeuroBo Pharmaceuticals, Inc.

Rx Communications Group

Michael Miller

+1-917-633-6086
[email protected]

Or

Dong-A ST Co., Ltd.

Hyung Heon Kim

E-mail: [email protected]

 

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SOURCE NeuroBo Pharmaceuticals, Inc.

Leading Center for Autism Education and Research has named Citius and Bartushak the 2022 Honorees for their annual Halloween Gala

CRANFORD, N.J. , Sept. 15, 2022 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Citius, along with the Company’s Chief Financial Officer and Chief Business Officer, Jaime Bartushak, were named as 2022 Honorees by the Somerset Hills Learning Institute (“The Institute”).  

The Institute is among the leading centers for autism education and research in the United States, forever changing the lives of people with autism with their unique blend of compassion and science. By integrating the compassion of its dedicated staff with cutting edge interventions, The Institute has provided its students with multiple opportunities to learn, play, and participate meaningfully with their families and in their communities.

“The Institute is a very special place that has benefited my entire family immeasurably. I am deeply honored to be recognized along with Citius as the 2022 Honorees,” stated Bartushak.

“Consistent with the literature, we have returned nearly half of the children who we’ve served before age five to their neighborhood schools to continue their education, needing no special support. These graduations produce significant savings to taxpayers. By returning students to their schools, we have saved NJ taxpayers more than $60 million,” said Dr. Kevin Brothers, The Institute’s Founding Executive Director. 

As school district tuition covers only a portion of what is costs to serve children with autism, The Institute must rely on fundraising to bridge their deficit each year. “The Halloween Ball is our largest event and as support for the Institute continues to grow, we have been fortunate to develop strong relationships with multiple generous individuals, businesses, and corporations. Citius has been among our army of very loyal supporters and Jaime Bartushak, in particular, also gives of his time and talent year after year planning and organizing our annual Golf Outing and Halloween Ball,” Brothers explained. “We are so grateful for these amazing partnerships.”

The 23rd Annual Halloween Ball will be held at The Grove in Cedar Grove, NJ on Friday, October 28th.

Founded in 1998, Somerset Hills Learning Institute is a private nonprofit program that offers a broad spectrum of services to children, adolescents, and adults with autism. The Institute exists to provide science-based treatment and education to people with autism. Somerset Hills Learning Institute prepares professionals as autism intervention resources in New Jersey, and through its research, pioneers comprehensive intervention models that may be used nationally and internationally for the benefit of people with autism. Please visit www.somerset-hills.org to learn more.    

Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company’s diversified pipeline includes two late-stage product candidates, Mino-Lok^®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), for which a BLA submission is being prepared for the second half of 2022.  Mino-Lok^® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids. The Company anticipates completing enrollment in the Halo-Lido trial by the end of 2022. For more information, please visit www.citiuspharma.com.

Investor Contact:

Ilanit Allen

[email protected] 
908-967-6677 x113

Media Contact:
STiR-communications
Greg Salsburg
[email protected]  

Somerset Hills Learning Institute:

Tara Ferrigno

[email protected]

908-719-6400

 

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SOURCE Citius Pharmaceuticals, Inc.

WOODSIDE, Calif.
, Sept. 15, 2022 /PRNewswire/ — Runway Growth Capital LLC (“Runway”), a leading provider of growth loans to both venture and non-venture backed companies seeking an alternative to raising equity, and Skyview Capital, LLC (“Skyview”), a global private investment firm specializing in the acquisition and management of mission critical enterprises in technology, telecommunications, business services and manufacturing, announced today a significant growth investment in Fidelis Cybersecurity (“Fidelis”).

The investment will provide working capital to enable Fidelis’ continued success in developing cyber solutions that help security teams from top commercial, enterprise, and government agencies worldwide find and stop threats faster and more effectively.

Fidelis is an industry innovator in Active eXtended Detection and Response (XDR) solutions that are trusted by Fortune 100 firms and government organizations worldwide. The company’s proactive cyber defense solutions provide advanced threat detection, deception, and response to safeguard modern IT environments across cloud, network and endpoints. 

“We are excited to reaffirm our commitment to Fidelis, who has been in Runway’s portfolio since May 2021,” said Greg Greifeld, Managing Director and Deputy Chief Investment Officer at Runway. “Fidelis is well-positioned in the high-growth cybersecurity market; they’re a stable business that has a strong executive team and low client churn.”

“There is so much to like about the cybersecurity sector right now. There is strong government backing (in the billions), high margins, and low customer churn rates when compared to other SaaS businesses,” said David Spreng, Founder and CEO at Runway. 

Fidelis plans to use the additional capital to continue its product development, build out its operational infrastructure, and fuel growth.

“Being endorsed by leading investment firms such as Skyview and Runway, affirms that Fidelis is well positioned to maximize growth opportunities that are being driven by a sizable government investment in cybersecurity and ongoing market consolidation,” explained Eric Moseman, President at Fidelis. “Runway’s long-standing partnership with Fidelis and the trust they have in our team and products, has enabled us to work from a position of strength in the rapidly evolving cybersecurity marketplace.”

Runway Growth Capital LLC is the investment advisor to investment funds, including Runway Growth Finance Corp. (Nasdaq: RWAY), a business development company, and other private funds, which are lenders of growth capital to companies seeking an alternative to raising equity. Led by industry veteran David Spreng, these funds provide senior term loans of $10 million to $75 million to fast-growing companies based in the United States and Canada. For more information on Runway Growth Capital LLC and its platform, please visit our website at www.runwaygrowth.com.

Statements included herein may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance, condition, or results and involve a number of risks and uncertainties. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described from time to time in Runway Growth’s filings with the Securities and Exchange Commission. Runway Growth undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.

Skyview Capital is a global private investment firm headquartered in Los Angeles, California, which specializes in the acquisition and management of mission critical enterprises in the areas of technology, telecommunications, business services and manufacturing. For more information, please visit www.skyviewcapital.com.

Fidelis Cybersecurity, the industry innovator in Active XDR and proactive cyber defense solutions, safeguards modern information technology (IT) environments with unparalleled detection, deception, response, cloud security, and compliance capabilities. We offer full visibility across hybrid environments via deep, dynamic asset discovery, multi-faceted context, and risk assessment. These features help minimize attackable surface areas, automate exposure prevention, threat detection, and incident response, and provide the context, accuracy, speed, and portability security professionals need to find and neutralize adversaries earlier in the attack lifecycle. Fidelis Cybersecurity is dedicated to helping clients become stronger and more secure. Fidelis is trusted by many top commercial, enterprise, and government agencies worldwide. For more information, please visit http://www.fidelissecurity.com/.

View original content:https://www.prnewswire.com/news-releases/fidelis-cybersecurity-secures-significant-additional-growth-investment-from-runway-growth-capital-and-skyview-capital-301624705.html

SOURCE Runway Growth Capital LLC

NEWARK, N.J.
, Sept. 15, 2022 /PRNewswire/ — Genie Energy Ltd., (NYSE: GNE, GNEPRA), a global provider of energy services, today announced that Avi Goldin, Genie’s chief financial officer, will present at the Sidoti September Small-Cap Virtual Conference on Wednesday, September 21, from 8:30 to 9:00 AM Eastern Time.

Goldin’s presentation will provide an overview of Genie Energy’s strategy, outlook and results. The live presentation can be accessed here:  https://protect-us.mimecast.com/s/31UZCPNlB2cqM56CzoCwp?domain=sidoti.zoom.us. 

Presentation materials will also be made available through the Genie Energy website.

Michael Stein, Genie Energy’s chief executive officer, and Goldin will be available for virtual 1×1 investor meetings throughout the day on Wednesday, September 21 and Thursday, September 22. Investors interested in a meeting with Genie management should contact Brian Siegel of Hayden IR ([email protected]) or request a meeting through the Sidoti conference portal.

About Genie Energy Ltd.: 

Genie Energy Ltd. (NYSE: GNE, GNEPRA), is a global provider of energy services.  The Genie Retail Energy division supplies electricity, including electricity from renewable resources, and natural gas to residential and small business customers in the United States. The Genie Retail Energy International division supplies customers in Scandinavia.  The Genie Energy Services division includes Diversegy, a commercial and industrial brokerage and consultative services company, and Genie Solar Energy and Prism Solar, which design, supply and install commercial solar solutions. For more information, visit Genie.com. 

View original content to download multimedia:https://www.prnewswire.com/news-releases/genie-energy-to-present-at-sidoti-september-small-cap-virtual-investor-conference-301625152.html

SOURCE Genie Energy Ltd.

Initial pilot in the operational area of Ben Gurion Airport

PETAH TIKVAH, Israel, Sept. 15, 2022 /PRNewswire/ —  SaverOne 2014 Ltd. (Nasdaq: SVRE) (TASE: SVRE), a technology company engaged in transportation safety solutions, today shared the following announcement made by the Israel Airports Authorities, operator of Ben Gurion Airport in Tel Aviv, a summary of which appears below:

The fighting of traffic accidents with the help of the SaverOne system in Israel: an initial pilot in the operational areas of Ben Gurion Airport will prevent drivers from using their cell phones, sending messages, etc.

The technology will help prevent accidents in the operational area of Ben Gurion Airport, an area which is full of vehicles and planes.

The SaverOne system, from an Israeli early-stage company with a solution for preventing mobile phone distraction while driving, was installed as a pilot trial in vehicles in the operational areas of Ben Gurion Airport.

The system installed in the vehicle disables a driver’s ability to use their cell phone while driving, except for receiving incoming calls, navigation and listening to music. The advantage of the pilot is that it does not interfere with receiving work instructions but does not allow unwanted active use of the cell phone. The system only affects the driver’s area, while other passengers are unrestricted and able to use their mobile phones as usual.

To date, the SaverOne system has also been installed by the Israel Electric Company, Osem, Tnuva, Strauss, ICL, Electra Afikim, as well as other companies.

Hagai Topolansky, CEO of the Israel Airport Authority, who instructed that the pilot should be implemented, commented, “An important element in improving our services, is the focus on safety in our operational areas and the improvement of services that we provide to the planes and airlines. We intend to fight accidents that may be caused by human distraction with the help of advanced technologies, combined with innovation and efficiency for passenger service.”

Following the announcement, Mr. Gilboa, CEO of SaverOne commented, “This represents our first penetration into an airport, a closed facility with highly sensitive, expensive, and critical equipment where potentially an accident will be very costly. Drivers use their phones for managing their workload and our system will ensure that this is done safely and they can drive without distraction within the sensitive areas of the airport. Airports are another highly strategic market for us and we see this as a first penetration into another vertical. We look forward to working closely with other airport authorities around the world to reduce accidents caused by distracted drivers within their sensitive operational areas.”  

About the SaverOne System

SaverOne systems can be installed in private vehicles, trucks and buses and provide a solution to the problem of driver distraction away from the road, that results from drivers using specific distracting applications on the mobile device while driving, in a way that endangers their safety and the safety of passengers. This phenomenon is considered one of the main causes of road accidents in the world. According to the US National Highway Traffic Safety Administration, the annual cost of road accidents just in the United States, stands at about $870 billion each year, excluding the costs of serious injury or death, with a quarter of those accidents estimated to be related to the use of the mobile device while driving.

SaverOne’s technology specifically recognizes the driver area in the vehicle and prevents the driver from accessing distracting applications such as messaging while allowing navigation, without user intervention or consent, creating a safer driving environment.

SaverOne’s primary target markets include commercial and private vehicle fleets, as well as insurance and leasing companies that are very interested in reducing potential damages and significant costs. SaverOne is initially addressing car fleets with focus on the Israeli, European and US markets, as well as other markets around the world. SaverOne believes that ultimately increased focus on monitoring and prevention of cellular distraction systems in vehicles, in particular driven by upcoming expected EU regulation, will likely have a dramatic positive impact on the demand for its systems in the future. The Company’s longer-term strategy is to address vehicle manufacturers, to install the Company’s protection technologies in the vehicle manufacturing process as an OEM.

About SaverOne

SaverOne is a technology company engaged in the design, development and commercialization of transportation safety solutions designed to save lives by preventing car accidents resulting from distraction, by the use of mobile phones while driving. The SaverOne system provides an advanced driver safety solution that can identify and monitor mobile phones located in the driver’s vicinity and selectively block use of distracting applications that may become life-threatening.

Learn more at https://saver.one/

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on SaverOne’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Many factors could cause SaverOne’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the ability of our technology to substantially improve the safety of drivers; our planned level of revenues and capital expenditures; our ability to market and sell our products; our plans to continue to invest in research and development to develop technology for both existing and new products; our intention to advance our technologies and commercialization efforts; our intention to use local distributors in each country or region that we will conduct business to distribute our products or technology; our plan to seek patent, trademark and other intellectual property rights for our products and technologies in the United States and internationally, as well as our ability to maintain and protect the validity of our currently held intellectual property rights; our expectations regarding future changes in our cost of revenues and our operating expenses; our expectations regarding our tax classifications; interpretations of current laws and the passage of future laws; acceptance of our business model by investors; the ability to correctly identify and enter new markets; the impact of competition and new technologies; general market, political and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; our intention to retain key employees, and our belief that we maintain good relations with all of our employees; the impact of the COVID-19 pandemic, and resulting government actions on us; and other risks and uncertainties, including those listed in the section titled “Risk Factors” in the final prospectus on Form 424b4 filed with the Securities and Exchange Commission on June 6, 2022. Forward-looking statements contained in this announcement are made as of this date, and SaverOne undertakes no duty to update such information except as required under applicable law.

International Investor Relations Contact:
Ehud Helft
+1 212 378 8040
[email protected]

Israeli Investors Contact:
Jonathan Eilat
[email protected]

View original content:https://www.prnewswire.com/news-releases/israel-airports-authority-announces-installation-of-saverone-systems-to-fight-traffic-accidents-301625210.html

SOURCE SaverOne